Deep infiltrating endometriosis: management by medical treatment versus early surgery: DIAMOND

Research question What is the clinical and cost-effectiveness of laparoscopic surgery (with or without adjuvant medical treatment) versus medical management alone in women with deep endometriosis (DE)? Background Endometriosis affects up to 10% of women of reproductive age and is chracterised by endometrial tissue growing outwith the uterine cavity. It causes inflammation and adhesions, which can lead to pain and infertility. DE, is a severe form of the condition where endometrial deposits are found more than 5 mm under the peritoneum or any of the following locations: between the rectum and vagina, the Pouch of Douglas, uterosacral ligaments, bowel, appendix, ureter, bladder, uterovesical fold and pelvic side wall. Laparoscopic excision of endometriosis has been shown to improve pain symptoms in DE. It is the only option in women with bowel or ureteric obstruction, but in others, hormonal treatment with the aim of shrinking areas of endometriosis has also been shown to relieve symptoms. Surgery for DE is very invasive and can cause bowel injury, septic peritonitis, rectovaginal fistula formation, stenosis, and bowel or bladder problems. Hormonal treatment is less risky, but can cause side-effects such as menopausal symptoms, and is incompatible with conception. A recent review of observational studies suggests that long-term hormonal treatment could be a viable alternative to surgery, but there are no randomised controlled trials to provide conclusive evidence. Aims and objectives To compare the clinical and cost-effectiveness of laparoscopic surgery versus medical treatment for the management of deep endometriosis in terms of condition specific quality of life measured using the pain domain of the Endometriosis Health Profile 30 and incremental cost per QALY gained at 18 months after randomisation. Secondary objectives: To compare surgical removal of DE with medical treatment in terms of pain, need for further medical treatment, gynaecological surgery, discontinuation of randomised treatment, serious adverse events, occupational outcomes and reproductive outcomes, indirect costs due to loss productivity and long term modelled cost effectiveness. Methods A multi-centre randomised controlled trial comparing early planned laparoscopic surgery versus medical management alone in women with DE (200 in each arm). Women presenting with pelvic pain associated with confirmed DE who are suitable for either surgical or medical management will be eligible. We will recruit from British Society of Gynaecology Endoscopy (BSGE) accredited endometriosis centres in the UK. A qualitative evaluation is embedded within the RCT to inform the delivery of the trial and explore the patient experience. Timelines for delivery The study duration is 54 months. Milestones: month 1-6, set-up, authorisations; months 7-30: patient recruitment; months 31-48: patient follow up to 18 months post randomisation; months 49-54: data analysis, interpretation of results, report writing and dissemination. Anticipated impact and dissemination If hormonal treatment is shown to be superior to surgery, uptake in clinical practice should be rapid as the intervention is relatively nexpensive, does not carry surgical and anaesthetic risks, and can be delivered easily and quickly. Results will be disseminated via Endometriosis UK, professional bodies NHS and university websites, open access journals, clinical practice guidelines and presentations in relevant conferences.